PRIMA SECURES EUROPEAN PATENT GRANT FOR LEAD PRODUCT IMP321 IN CANCER

On November 22, 2017 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima", the "Company") reported the grant of patent number 2604275 entitled "Use of Recombinant LAG-3 or the Derivatives thereof for Eliciting Monocyte Immune Response" by the European Patent Office (Press release, Prima Biomed, NOV 22, 2017, View Source [SID1234522226]).

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This European patent was filed as a divisional application and follows the grant of the European parent patent, which was issued in August 2013.

The claims of this new patent are geared toward the use of Prima’s lead candidate IMP321 in combination with a chemotherapeutic agent for the treatment of cancer. According to the claims, IMP321 elicits a monocyte-mediated immune response and is administered before, with, or subsequent to administration of the chemotherapeutic agent. Importantly, these granted claims support the application of IMP321 in Prima’s AIPAC clinical trial in metastatic breast cancer in Europe.
The patent expiry date is 3 October 2028.

TESARO Announces Participation in Two Investor Conferences

On November 22, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported its participation in two upcoming investor conferences (Press release, TESARO, NOV 22, 2017, View Source [SID1234522235]). The two conferences are:

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The Citi 2017 Global Healthcare Conference at the Lotte New York Palace in New York, New York on Thursday, December 7. Lonnie Moulder, CEO of TESARO, and Mary Lynne Hedley, Ph.D., President and COO of TESARO, will participate in an analyst-led moderated Q&A from 1:25 to 2:05 PM ET and in meetings with investors.

The Guggenheim Securities 5th Annual Boston Healthcare Conference at the Intercontinental in Boston, Massachusetts on Wednesday, December 13. Tim Pearson, Executive Vice President and CFO of TESARO, will participate in meetings with investors.
A live webcast of the analyst-led Q&A discussion at the Citi conference will be available by visiting the Investors section of the TESARO website at www.tesarobio.com. An archived replay of this webcast will be available on the Company’s website for 14 days following the conference.

Puma Biotechnology and Specialised Therapeutics Asia Enter into Exclusive Licensing Agreement to Commercialize NERLYNX® (neratinib) in Australia, New Zealand and South East Asia

On November 22, 2017 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, and Specialised Therapeutics Asia, an international biopharmaceutical company with strategic focus and expertise in Australia, New Zealand and South East Asia, reported that they have entered into an exclusive agreement under which Specialised Therapeutics will commercialize NERLYNX (neratinib) throughout South East Asia, beginning with Australia, Singapore, Malaysia, Brunei and New Zealand. Currently, Specialised Therapeutics markets Abraxane and other oncology products in these countries (Press release, Prima Biomed, NOV 22, 2017, View Source [SID1234522226]).

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NERLYNX is not approved currently for commercialization outside of the United States. Specialised Therapeutics will be responsible for seeking the requisite regulatory approvals and, once approved, for commercializing NERLYNX in those countries. Puma will receive upfront and milestone payments of up to $4.5 million throughout the term of this agreement, as well as significant double digit royalties on NERLYNX sales in all regions in which Specialised Therapeutics commercializes NERLYNX.

"Our new agreement with Specialised Therapeutics demonstrates our commitment to bringing NERLYNX to patients around the world while continuing to focus our commercial resources on the U.S. market," stated Alan H. Auerbach, Chief Executive Officer and President of Puma. "We are confident this new partnership will help patients in our new partner’s regions access NERLYNX at the earliest opportunity."

"We are thrilled to be selected as Puma’s first international partner able to provide this therapy to women in our region. We plan to expedite access to this important therapy with a Special Access Program, which we expect to open in Australia in the first quarter of 2018. In tandem, we plan to file for Therapeutic Goods Administration (TGA) registration and to seek regulatory approval to market in other countries, including Singapore, Malaysia, Brunei and New Zealand," said Carlo Montagner, Chief Executive Officer of Specialised Therapeutics. "We expect to have regulatory approval for NERLYNX in Australia by the second quarter of 2019."

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

IMPORTANT SAFETY INFORMATION

NERLYNX (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

Diarrhea: Aggressively manage diarrhea occurring despite recommended prophylaxis with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

DRUG INTERACTIONS:

Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors (PPI) and H2-receptor antagonists. Separate NERLYNX by 3 hours after antacid dosing.
Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.
Strong or moderate CYP3A4 inducers: Avoid concomitant use.
P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.
USE IN SPECIFIC POPULATIONS:

Lactation: Advise women not to breastfeed.
Please see Full Prescribing Information for additional safety information.

The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the first 2 months (56 days) of treatment and as needed thereafter.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

ImmuncoCellular Therapeutics to Present at the 10th Annual LD Micro Main Event on December 7, 2017

On November 22, 2017 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE American: IMUC), a biotechnology company developing immunotherapies for the treatment of cancer based on Stem-to-T-Cell research, reported that that Anthony Gringeri, Ph.D., President and Chief Executive Officer, Steven Swanson, Ph.D., Senior Vice President, Research, and David Fractor, Chief Financial Officer, will present at the 10th Annual LD Micro Main Event on Thursday, December 7, 2017 at 9:30 a.m. PT (12:30 p.m. ET) in Track 3 (Press release, ImmunoCellular Therapeutics, NOV 22, 2017, View Source [SID1234522218]). The conference is being held at the Luxe Sunset Boulevard Hotel in Los Angeles, CA.

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Management will be available for one-on-one meetings on Thursday, December 7, 2017. Investors interested in arranging a meeting with management should contact their LD Micro representative or Lytham Partners at (602) 889-9700 or [email protected].

Interested parties who wish to listen to the webcast of the ImmunoCellular LD Micro presentation should visit the Investor Relations section of ImmunoCellular’s website at www.imuc.com, under the Events and Presentations tab. A replay of the webcast will be available one hour after the conclusion of the event. The webcast will contain forward-looking statements. The information provided on the webcast is accurate only at the time of the webcast, and ImmunoCellular will take no responsibility for providing updated information except as required by law.

Medtronic Reports Second Quarter Financial Results

On November 21, 2017 Medtronic plc (NYSE:MDT) reported financial results for its second quarter of fiscal year 2018, which ended October 27, 2017 (Press release, Medtronic, NOV 21, 2017, View Source;p=RssLanding&cat=news&id=2318070 [SID1234522197]).

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The company reported second quarter worldwide revenue of $7.050 billion, a decrease of 4 percent as reported, with the decline driven by the company’s divestiture of its Patient Care, Deep Vein Thrombosis (Compression), and Nutritional Insufficiency businesses to Cardinal Health that occurred at the beginning of the quarter. Second quarter revenue increased 3 percent on a comparable, constant currency basis, which adjusts for the divestiture and a $35 million positive impact from foreign currency. Excluding the approximate $55 to $65 million impact of Hurricane Maria to the company’s revenue, which was split across the company’s Minimally Invasive Therapies Group and Restorative Therapies Group, second quarter revenue growth would have been 4 percent on a comparable, constant currency basis.

As reported, second quarter GAAP net income and diluted earnings per share (EPS) were $2.017 billion and $1.48, respectively. As detailed in the financial schedules included through the link at the end of this release, second quarter non-GAAP net income and diluted EPS were $1.456 billion and $1.07, decreases of 7 percent and 4 percent, respectively. Adjusting for the divestiture, a positive 1 cent impact from foreign currency, and the approximate 3 cent impact from Hurricane Maria, second quarter non-GAAP diluted EPS increased approximately 5 percent.

Second quarter U.S. revenue of $3.734 billion represented 53 percent of company revenue and decreased 10 percent as reported, or was flat on a comparable basis. Non-U.S. developed market revenue of $2.241 billion represented 32 percent of company revenue and increased 1 percent as reported, or 5 percent on a comparable, constant currency basis. Emerging market revenue of $1.075 billion represented 15 percent of company revenue and increased 9 percent as reported, or 12 percent on a comparable, constant currency basis.

"Our second quarter financial results are very encouraging, when considered in the context of a quarter in which we faced three hurricanes and the California wildfires. Hurricane Maria, in particular, significantly affected our manufacturing operations in Puerto Rico," said Omar Ishrak, Medtronic chairman and chief executive officer. "Against this backdrop, we delivered a sequential acceleration in our organic revenue growth, as expected."

Cardiac and Vascular Group

The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic & Peripheral Vascular (APV) divisions. CVG worldwide second quarter revenue of $2.773 billion increased 7 percent on both a reported and constant currency basis. CVG revenue performance was driven by strong, low-double digit growth in CSH and mid-single digit growth in CRHF and APV, all on a constant currency basis.

CRHF second quarter revenue of $1.467 billion increased 5 percent, or 4 percent on a constant currency basis. Arrhythmia Management grew in the mid-single digits on a constant currency basis, driven by high-teens growth in AF Solutions and low-double digit growth in Diagnostics, both on a constant currency basis, as well as strong adoption of the Micra(TM) Transcatheter Pacing System and TYRX(TM) absorbable antibacterial envelope. Heart Failure grew in the high-single digits on a constant currency basis, driven by strong demand for the company’s portfolio of quadripolar cardiac resynchronization therapy-pacemakers (CRT-P), as well as growth in Mechanical Circulatory Support.
CSH second quarter revenue of $854 million increased 13 percent, or 12 percent on a constant currency basis, led by high-thirties growth on a constant currency basis in transcatheter aortic valves on the strength of the recently launched CoreValve Evolut PRO and U.S. intermediate risk indication. In addition, the Coronary business returned to growth, driven by the company’s recent launch of the Resolute Onyx(TM) drug-eluting stent in the U.S. and Japan.
APV second quarter revenue of $452 million increased 5 percent, or 4 percent on a constant currency basis. Aortic growth was led by the solid adoption of the Heli-FX EndoAnchor System and solid performance of the Valiant Captivia thoracic stent graft systems. Peripheral was driven by double digit growth in both PTA balloons and drug-coated balloons. Mid-single digit growth in endoVenous was driven by the recently launched Concerto(TM) 3D detachable coil system.
Minimally Invasive Therapies Group

The Minimally Invasive Therapies Group (MITG) is now organized into the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions following the divestiture of its Patient Care, Deep Vein Thrombosis (Compression), and Nutritional Insufficiency (Enteral Feeding) businesses. MITG worldwide second quarter revenue of $1.952 billion decreased 21 percent as reported, or increased 2 percent on a comparable, constant currency basis. MITG second quarter revenue growth reflected mid-single digit growth in SI, which was affected by Hurricane Maria, offset by low-single digit declines in RGR.

SI second quarter revenue of $1.334 billion increased 4 percent on a comparable, constant currency basis, driven by new products in Advanced Stapling and Advanced Energy, including endo stapling specialty reloads, the Signia(TM) powered stapler, and LigaSure(TM) vessel sealing instruments.
RGR second quarter revenue of $618 million decreased 3 percent on a comparable, constant currency basis. The declines were driven by difficult comparisons in its Respiratory business following the return to market last year of the Puritan Bennett(TM) 980 ventilator.
Restorative Therapies Group

The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions. RTG worldwide second quarter revenue of $1.863 billion increased 2 percent on both a reported and constant currency basis. Group results were driven by low-double digit growth in Brain Therapies, offsetting declines in Spine, Specialty Therapies, and Pain Therapies, all on a constant currency basis. Hurricane Maria primarily affected the Spine and Pain Therapies division, as well as the Pelvic Health business in the Specialty Therapies division.

Spine second quarter revenue of $659 million decreased 1 percent on both a reported and constant currency basis. Mid-single digit constant currency growth in Biologics worldwide and low-single digit constant currency growth in Core Spine in international markets was offset by mid-single digit declines in Core Spine in the U.S. as a result of the impact of Hurricane Maria.
Brain Therapies second quarter revenue of $575 million increased 14 percent, or 13 percent on a constant currency basis. Growth was driven by high-twenties constant currency growth in Neurovascular, with strength across its product portfolio. The Neurosurgery business grew in the mid-teens on a constant currency basis, led by strong sales of the StealthStation(TM) S8 surgical navigation system, O-arm2 surgical imaging system, Visualase MRI-guided laser ablation system, and Midas Rex surgical instruments.
Specialty Therapies second quarter revenue of $365 million decreased 1 percent on both a reported and constant currency basis. Mid-single digit global constant currency growth in Transformative Solutions, ENT, and high-single digit international constant currency growth in Pelvic Health was offset by mid-single digit declines in Pelvic Health in the U.S., with the declines driven by the impact of Hurricane Maria on InterStim II sales.
Pain Therapies second quarter revenue of $264 million decreased 8 percent, or 9 percent on a constant currency basis. Growth in Interventional Pain was offset by mid-teens declines in Spinal Cord Stimulation and mid-single digit declines in Pain Pumps, all on a constant currency basis, driven in part by the impact of Hurricane Maria.
Diabetes Group

The Diabetes Group includes the Intensive Insulin Management (IIM), Diabetes Service & Solutions (DSS), and Non-Intensive Diabetes Therapies (NDT) divisions. Diabetes Group worldwide second quarter revenue of $462 million was flat, or decreased 2 percent on a constant currency basis. The group is experiencing strong global demand for its new sensor-augmented insulin pump systems, and similar to the first quarter, growth was tempered as demand outpaced supply. The group’s ability to meet increasing patient demand has improved, as evidenced by the improved sequential revenue growth. In addition, the Diabetes Group’s capacity expansion plans for the second half of fiscal year 2018 are on track.

IIM second quarter revenue declined in the low-single digits on a constant currency basis. In the U.S., IIM experienced a 15 percent growth in new patients. This was offset by delays in converting its existing installed base to new pumps due to CGM sensor supply constraints. In international markets, IIM delivered high-single digit constant currency growth due to the continued strength of the MiniMed 640G system.
DSS second quarter revenue was flat on a constant currency basis. In the U.S., consumables benefited from installed base growth and improved patient utilization, which was offset by price declines and increased payer requirements. In international markets, the Diabeter business had mid-twenties patient growth, while in consumables, installed base growth was offset by temporary market pressures in China and France.
NDT second quarter revenue declined in the high-twenties on a constant currency basis given the temporarily limited supply of sensors for professional CGM. However, the division had 60 percent new account growth in US primary care.
Guidance

Medtronic today reiterated its revenue and non-GAAP EPS guidance. The company’s guidance is given on a comparable, constant currency basis, which accounts for the divestiture of certain businesses from its prior period Patient Monitoring & Recovery division by removing the financial impact of these businesses from the second, third, and fourth quarters of fiscal year 2017, as well as removing the impact of foreign currency.

In fiscal year 2018, the company continues to expect comparable, constant currency revenue growth to be in the range of 4 to 5 percent. While the impact of foreign currency remains fluid, if current exchange rates remain similar for the remainder of the fiscal year, the company’s revenue would be positively affected by approximately $275 million to $375 million for the fiscal year, including an approximate $155 to $175 million positive impact in the third fiscal quarter.

In fiscal year 2018, the company continues to expect diluted non-GAAP EPS growth to be in the range of 9 to 10 percent on a comparable, constant currency basis from the prior year comparable EPS of $4.37. Assuming current exchange rates remain similar for the rest of the year, the foreign exchange impact on the company’s non-GAAP EPS would be approximately negative 2 cents for the fiscal year, including an approximate positive 1 cent impact in the third fiscal quarter.

"We are seeing increased revenue momentum from several important new product launches, which we expect to continue into the second half of the fiscal year," said Ishrak. "The combination of our growth momentum, business and geographic diversification, as well as our scale in markets around the world contribute to our goal of delivering increasingly consistent and dependable results for our shareholders."

Webcast Information

Medtronic will host a webcast today, November 21, at 8:00 a.m. EST (7:00 a.m. CST) to provide information about its businesses for the public, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on our Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Financial Schedules

To view the second quarter financial schedules and non-GAAP reconciliations, click here. To view the second quarter earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.